Drugs Details

Drugs Info of HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB
Drugs Details
  • Drugs Type  : FDA
  • Date : 21st Feb 2015 01:52 am
  • Brand Name : HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB
  • Generic Name : hepatitis B immune globulin (Pronunciation: HEP a TYE tis B im MYOON GLOB yoo lin)
Descriptions

Hepatitis B Immune Globulin (Human), Nabi-HB (hepatitis b vaccine recombinant) , is a sterile solution of immunoglobulin (5 ± 1% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is processed using a modified Cohn 6 / Oncley 9 cold-alcohol fractionation process1,2 with two added viral reduction steps described below. Nabi-HB (hepatitis b vaccine recombinant) is formulated in 0.075 M sodium chloride, 0.15 M glycine, and 0.01% polysorbate 80, at pH 6.2. The product is supplied as a nonturbid sterile liquid in single dose vials and appears as clear to opalescent. It contains no preservative and is intended for single use by the intramuscular route only.

The manufacturing steps for Nabi-HB (hepatitis b vaccine recombinant) are designed to reduce the risk of transmission of viral disease. The solvent/detergent treatment step, using tri-n-butyl phosphate and Triton® X-100, is effective in inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)3. Virus filtration, using a Planova® 35 nm Virus Filter, is effective in reducing some known enveloped and non-enveloped viruses4. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in the following table:

Table 1 : Log Reduction of Test Viruses5

  Test Virus
  HIV BVD PRV EMC PPV
Model Virus: HIV HCV HBV Hepatitis A PVB19
Envelope/Genome: yes/RNA yes/RNA yes/DNA no/RNA no/DNA
Manufacturing Step
Precipitation of Cohn Fraction III > 5.9 3.6 3.7 4.4 3.9
Cuno Filtration NT NT NT > 6.6 5.4
Solvent/Detergent > 4.2 > 6.9 > 6.4 NT NT
Nanofiltration > 7.4 > 6.9 > 5.7 3.0 0.7 *
Cumulative > 17.5 > 17.4 > 15.8 > 14.0 9.3
BVD = Bovine Viral Diarrhea Virus
EMC = Encephalomyocarditis Virus
HIV = Human Immunodeficiency Virus
PVB19 = Parvovirus B19
PPV = Porcine Parvovirus
PRV = Pseudorabies Virus
NT = not tested
* Value not included in cumulative clearance

Product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. Each milliliter (mL) of product contains greater than 312 IU anti-HBs. The potency of each milliliter of Nabi-HB (hepatitis b vaccine recombinant) exceeds the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (FDA). The U.S. reference has been tested by Nabi® Biopharmaceuticals against the WHO standard and found to be equal to 208 IU/mL.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Nabi-HB »

What are the precautions when taking hepatitis b vaccine recombinant (Nabi-HB)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is made from human...

Read All Potential Precautions of Nabi-HB »

REFERENCES

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Nabi-HB »

What are the precautions when taking hepatitis b vaccine recombinant (Nabi-HB)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is made from human...

Read All Potential Precautions of Nabi-HB »

1. Cohn E.J., Strong W.L., Mulford D.J., Ashworth J.N., Melin M., Taylor H.L. Preparation and Properties of Serum and Plasma Proteins IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 1946, 68: 459-475.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Nabi-HB »

What are the precautions when taking hepatitis b vaccine recombinant (Nabi-HB)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is made from human...

Read All Potential Precautions of Nabi-HB »

2. Oncley J.L, Melin M, Richert D.A, Cameron J. W, Gross P.M. The separation of antibodies, isoagglutinins, prothrombin, plasminogen and b1-lipoproteins into sub-fractions of human plasma. J Am Chem Soc 1949, 71:541-550.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Nabi-HB »

What are the precautions when taking hepatitis b vaccine recombinant (Nabi-HB)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is made from human...

Read All Potential Precautions of Nabi-HB »

3. Horowitz B: Investigations into the application of tri(n-butyl)phosphate/detergent mixtures to blood derivatives. Morgenthaler J (ed): Virus Inactivation in Plasma Products, Curr Stud Hematol Blood Transfus 1989; 56:83-96.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Nabi-HB »

What are the precautions when taking hepatitis b vaccine recombinant (Nabi-HB)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is made from human...

Read All Potential Precautions of Nabi-HB »

4. Burnouf T: Value of virus filtration as method for improving the safety of plasma products. Vox Sang 1996; 70:235-236.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Nabi-HB »

What are the precautions when taking hepatitis b vaccine recombinant (Nabi-HB)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is made from human...

Read All Potential Precautions of Nabi-HB »

5. Unpublished data on file, Viral Validation Study Reports, Nabi® Biopharmaceuticals.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of Nabi-HB »

What are the precautions when taking hepatitis b vaccine recombinant (Nabi-HB)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is made from human...

Read All Potential Precautions of Nabi-HB »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings:

  • Acute Exposure to Blood Containing HBsAg
    Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum.
  • Perinatal Exposure of Infants Born to HBsAg-positive Mothers
    Infants born to mothers positive for HBsAg with or without HBeAg12.
  • Sexual Exposure to HBsAg-positive Persons
    Sexual partners of HBsAg-positive persons.
  • Household Exposure to Persons with Acute HBV Infection
    Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg.
    Other household contacts with an identifiable blood exposure to the index patient.

Nabi-HB (hepatitis b vaccine recombinant) is indicated for intramuscular use only.

Dosage Administration

This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to prevent transmission of infectious agents from one person to another. Any vial of Nabi-HB, Hepatitis B Immune Globulin (Human) that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately.

Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine11.

  • Acute Exposure to Blood Containing HBsAg
    Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure, as its value after seven days following exposure is unclear12. An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult the hepatitis B vaccine package insert for dosage information regarding the vaccine.

    For persons who refuse hepatitis B vaccine or are known non-responders to vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given one month after the first dose12.

Table 2 : Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure12

  Exposed Person
Source Unvaccinated Vaccinated
HBsAg-positive
  1. Hepatitis B Immune Globulin (Human) X 1 immediately*
  2. Initiate HB vaccine series†
  1. Test exposed person for anti-HBs
  2. If inadequate antibody&Daffer;, Hepatitis B Immune Globulin (Human) X 1 immediately plus either HB vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later§
Known Source - High Risk for HBsAg-positive
  1. Initiate HB vaccine series
  2. Test source for HBsAg. If positive, Hepatitis B Immune Globulin (Human) X 1
  1. Test source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give Hepatitis B Immune Globulin (Human) X 1 immediately plus either HB vaccine booster dose or second dose of Hepatitis B Immune Globulin (Human) one month later§
Known Source - Low Risk for HBsAg-positive Initiate HB vaccine series Nothing required
Unknown Source Initiate HB vaccine series Nothing required
* Hepatitis B Immune Globulin (Human) dose of 0.06 mL/kg IM.
† See manufacturers' recommendation for appropriate dose.
‡ Less than 10 mIU/mL anti-HBs by radioimmunoassay, negative by enzyme immunoassay.
§ Two doses of Hepatitis B Immune Globulin (Human) is preferred if no response after at least four doses of vaccine.
  • Prophylaxis of Infants Born to Mothers who are Positive for HBsAg with or without HBeAg
    Table 3 contains the recommended schedule of hepatitis B prophylaxis for infants born to mothers that are either known to be positive for HBsAg or have not been screened. Infants born to mothers known to be HBsAg-positive should receive 0.5 mL Hepatitis B Immune Globulin (Human) after physiologic stabilization of the infant and preferably within 12 hours of birth. The hepatitis B vaccine series should be initiated simultaneously, if not contraindicated, with the first dose of the vaccine given concurrently with the Hepatitis B Immune Globulin (Human), but at a different site. Subsequent doses of the vaccine should be administered in accordance with the recommendations of the manufacturer.

Women admitted for delivery, who were not screened for HBsAg during the prenatal period, should be tested. While test results are pending, the newborn infant should receive hepatitis B vaccine within 12 hours of birth (see manufacturers' recommendations for dose). If the mother is later found to be HBsAg-positive, the infant should receive 0.5 mL Hepatitis B Immune Globulin (Human) as soon as possible and within seven days of birth; however, the efficacy of Hepatitis B Immune Globulin (Human) administered after 48 hours of age is not known10,19. Testing for HBsAg and anti-HBs is recommended at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been protected12.

Table 3 : Recommended Schedule of Hepatitis B Immunoprophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus Infection 19

  Age of Infant
Administer Infant Born to mother known to be HBsAg-positive Infant born to mother not screened for HBsAg
First Vaccination* Birth (within 12 hours) Birth (within 12 hours)
Hepatitis B Immune Globulin (Human)† Birth (within 12 hours) If mother is found to be HBsAg-positive, administer dose to infant as soon as possible, not later than 1 week after birth
Second Vaccination* 1 month 1-2 months
Third Vaccination* 6 months‡ 6 months‡
* See manufacturers' recommendations for appropriate dose.
† 0.5 mL administered IM at a site different from that used for the vaccine.
‡See ACIP recommendation.
  • Sexual Exposure to HBsAg-positive Persons
    All susceptible persons whose sexual partners have acute hepatitis B infection should receive a single dose of Hepatitis B Immune Globulin (Human) (0.06 mL/kg) and should begin the hepatitis B vaccine series, if not contraindicated, within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine with Hepatitis B Immune Globulin (Human) may improve the efficacy of post exposure treatment. The vaccine has the added advantage of conferring long-lasting protection19.
  • Household Exposure to Persons with Acute HBV Infection
    Prophylaxis of an infant less than 12 months of age with 0.5 mL Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless they had an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine19.

How Supplied

Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as:

 

NDC Number Contents
59730-4202-1 a carton containing a 1 mL dose in a single-use vial ( > 312 IU) and
59730-4204-1 package insert
59730-4203-1 a carton containing a 5 mL dose in a single-use vial ( > 1560 IU) and
59730-4205-1 package insert

Storage

Refrigerate between 2 to 8 °C (36 to 46 °F). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.

REFERENCES

10.Beasley RP, et al.: Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: Final report of a randomized double-blind, placebo - controlled trial. Hepatology 1983; 3:135-141.

11.Szmuness W, et al.: Passive active immunisation against hepatitis B: Immunogenicity studies in adult Americans. Lancet 1981; 1:575-577.

12.Centers for Disease Control: Recommendations for protection against viral hepatitis. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1985; 34(22):313-335.

19.Centers for Disease Control: Hepatitis B virus: A comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991; 40(13):1-25.

Manufactured by: Nabi® Biopharmaceuticals Boca Raton, FL 33487. June 2003.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials20. The number of patients with reactions related to the administration of Nabi-HB (hepatitis b vaccine recombinant) included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myal-gia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The following adverse events were reported in the phar-macokinetics trials and were considered probably related to Nabi-HB (hepatitis b vaccine recombinant) : elevated alkaline phos-phatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were mild in intensity. There were no serious adverse events.

No anaphylactic reactions with Nabi-HB (hepatitis b vaccine recombinant) have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins23.

Read the Nabi-HB (hepatitis b vaccine recombinant) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Vaccination with live virus vaccines should be deferred until approximately three months after administration of Nabi-HB, Hepatitis B Immune Globulin (Human). It may be necessary to revaccinate persons who received Nabi-HB (hepatitis b vaccine recombinant) shortly after live virus vaccination.

There are no available data on concomitant use of Nabi-HB (hepatitis b vaccine recombinant) and other drugs; therefore, Nabi-HB (hepatitis b vaccine recombinant) should not be mixed with other drugs.

REFERENCES

20. Data on file, Nabi® Biopharmaceuticals

23. Ellis EF, Henney CS: Adverse reactions following administration of human gamma globulin. J Allerg 1969; 43:45-54.

Read the Nabi-HB Drug Interactions Center for a complete guide to possible interactions

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This monograph has been modified to include the generic and brand name in many instances.

Warnings

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB, Hepatitis B Immune Globulin (Human), should be given only if the expected benefits outweigh the potential risks.

Nabi-HB is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products can transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections, and by inactivating and/or reducing certain viruses. The Nabi-HB (hepatitis b vaccine recombinant) manufacturing process includes a solvent/detergent treatment step (using tri-n-butyl phosphate and Triton® X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV. Nabi-HB (hepatitis b vaccine recombinant) is filtered using a Planova® 35 nm Virus Filter that is effective in reducing the levels of some enveloped and non-enveloped viruses. These two processes are designed to increase product safety. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health care provider to Nabi® Biopharmaceuticals at 1-800-458-4244. The physician should discuss the risks and benefits of this product with the patient.

Precautions

General

Nabi-HB, Hepatitis B Immune Globulin (Human), must be administered only intramuscularly for post-exposure prophylaxis. The preferred sites for intramuscular injections are the anterolateral aspect of the upper thigh and the deltoid muscle. If the buttock is used due to the volume to be injected, the central region should be avoided; only the upper, outer quadrant should be used, and the needle should be directed anterior (i.e., not inferior or perpendicular to the skin) to minimize the possibility of involvement with the sciatic nerve22.

The 50 healthy volunteers who received Nabi-HB (hepatitis b vaccine recombinant) in pharmacokinetic studies were followed for 84 days for possible development of anti-HCV antibodies. No subject seroconverted.

Pregnancy Category C

Animal reproduction studies have not been conducted with Nabi-HB (hepatitis b vaccine recombinant) . It is also not known whether Nabi-HB (hepatitis b vaccine recombinant) can cause fetal harm when administered to a pregnant woman or can affect a woman's ability to conceive. Nabi-HB (hepatitis b vaccine recombinant) should be given to a pregnant woman only if clearly indicated.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nabi-HB (hepatitis b vaccine recombinant) is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established for Nabi-HB (hepatitis b vaccine recombinant) . However, the safety and effectiveness of similar hepatitis B immune globulins have been demonstrated in infants and children12.

Geriatric Use

Clinical studies of Nabi-HB (hepatitis b vaccine recombinant) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

REFERENCES

12. Centers for Disease Control: Recommendations for protection against viral hepatitis. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1985; 34(22):313-335.

22. Centers for Disease Control: General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1994; 43:1-38.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Although no data are available, clinical experience reported with other human immune globulins suggests that the only manifestations of overdose with Nabi-HB, Hepatitis B Immune Globulin (Human), would be pain and tenderness at the injection site.

ContrainDications

Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB, Hepatitis B Immune Globulin (Human), or any other human immune globulin. Nabi-HB (hepatitis b vaccine recombinant) contains less than 100 micrograms per mL IgA. Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have an anaphylac-toid reaction. The physician must weigh the potential benefit of treatment with Nabi-HB (hepatitis b vaccine recombinant) against the potential for hypersensitivity reactions.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Hepatitis B Immune Globulin (Human) products provide passive immunization for individuals exposed to the hepatitis B virus as evidenced by a reduction in the attack rate of hepatitis B following use6-9.

Clinical studies10,11 conducted prior to 1983 with hepatitis B immune globulins similar to Nabi-HB (hepatitis b vaccine recombinant) indicate the advantage of simultaneous administration of hepatitis B vaccine and Hepatitis B Immune Globulin (Human). The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) advises that the combination prophylaxis be provided in certain instances of exposure based upon the increased efficacy found with that regimen in neonates12. Cases of hepatitis B are rarely seen following exposure to HBV in persons with preexisting anti-HBs. However, no prospective studies have been performed on the efficacy of concurrent hepatitis B vaccine and Hepatitis B Immune Globulin (Human) administration following parenteral exposure, mucous membrane contact, or oral ingestion in adults.

Infants born to HBsAg-positive mothers are at risk of being infected with HBV and becoming chronic carriers13. The risk is especially great if the mother is also HBeAg-positive14. Studies conducted with hepatitis B immune globulins similar to Nabi-HB (hepatitis b vaccine recombinant) indicated that for an infant with peri-natal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85-98% effective in preventing development of the HBV carrier state15-17. Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have a 70-90% efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has 50% efficacy18.

Since infants have close contact with primary caregivers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection19.

Sexual partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. A single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within two weeks of the last sexual exposure to a person with acute hepatitis B19.

Pharmacokinetics

Pharmacokinetics trials20 of Nabi-HB, Hepatitis B Immune Globulin (Human), given intramuscularly to 50 healthy volunteers demonstrated pharmacokinetic parameters similar to those reported by Scheiermann and Kuwert21. The half-life for Nabi-HB (hepatitis b vaccine recombinant) was 23.1 ± 5.5 days. The clearance rate was 0.35 ± 0.12 L/day and the volume of distribution was 11.2 ± 3.4 L.

Maximum concentration of Nabi-HB (hepatitis b vaccine recombinant) was reached in 6.5 ±4.3 days. The maximum concentration of anti-HBs and the area under the time-concentration curve achieved by Nabi-HB (hepatitis b vaccine recombinant) were bio-equivalent to that of another licensed Hepatitis B Immune Globulin (Human) when compared in the same pharmacokinetics trial. Comparability of pharmacokinetics between Nabi-HB (hepatitis b vaccine recombinant) and a commercially available hepatitis B immunoglobulin indicate that similar efficacy of Nabi-HB (hepatitis b vaccine recombinant) should be inferred.

REFERENCES

6. Grady GF, and Lee VA: Hepatitis B immune globulin - prevention of hepatitis from accidental exposure among medical personnel. N Engl J Med 1975; 293:1067-1070.

7. Seeff LB, et al.: Type B hepatitis after needle-stick exposure: Prevention with hepatitis B immune globulin. Ann Int Med 1978; 88:285-293.

8. Krugman S, and Giles JP: Viral hepatitis, type B (MS-2-strain). Further observations on natural history and prevention. N Engl J Med 1973; 288:755-760.

9. Hoofnagle JH, et al.: Passive - active immunity from hepatitis B immune globulin. Ann Int Med 1979; 91:813-818.

10. Beasley RP, et al.: Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: Final report of a randomized double-blind, placebo - controlled trial. Hepatology 1983; 3:135-141.

11. Szmuness W, et al.: Passive active immunisation against hepatitis B: Immunogenicity studies in adult Americans. Lancet 1981; 1:575-577.

12. Centers for Disease Control: Recommendations for protection against viral hepatitis. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1985; 34(22):313-335.

13. Shiraki Y, et al.: Hepatitis B surface antigen and chronic hepatitis in infants born to asymptomatic carrier mothers. Am J Dis Child 1977; 131:644-647.

14. Beasley RP, et al.: The e antigen and vertical transmission of hepatitis B surface antigen. Am J Epidemiol 1977; 105:94-98.

15. Wong VCW, et al.: Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis B vaccine and hepatitis B immunoglobulin: Double-blind randomized placebo-controlled study. Lancet 1984; 1:921-926.

16. Poovorawan Y, et al.: Long term hepatitis B vaccine in infants born to hepatitis B e antigen positive mothers. Archives of Diseases in Childhood 1997; 77:F47-F51.

17. Stevens CE, et al.: Perinatal Hepatitis B virus transmission in the United States: Prevention by passive-active immunization. JAMA 1985; 253:1740-1745.

18. Jhaveri R, et al.: High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive mothers. J Pediatr 1980; 97:305-308.

19. Centers for Disease Control: Hepatitis B virus: A comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991; 40(13):1-25.

20. Data on file, Nabi® Biopharmaceuticals

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

HEPATITIS B IMMUNE GLOBULIN - INJECTION

 

(hep-a-TYE-tis bee i-MYUN-GLOB-yoo-lin)

 

COMMON BRAND NAME(S): Hepagam B, Hyperhep B S-D, Nabi-HB

 

WARNING: This medication may rarely cause serious blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist.

Being adequately hydrated before and after receiving this medication may help reduce your risk of blood clots. If you are receiving this medication into a vein, the risk may also be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available.

Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the arm/leg, sudden/severe headache, slurred speech, weakness on one side of the body, sudden vision changes, or confusion.

 

USES: This medication is used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). Certain brands of this medication may also be given after a liver transplant to prevent return of hepatitis B infection in people with previous infection. Ask your doctor or pharmacist if you have questions about your particular brand. This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies) that help fight hepatitis B.

 

HOW TO USE: If this medication is given for prevention of hepatitis B after direct exposure to the virus, it is given by injection into a muscle by a healthcare professional. It is best to receive this medication as soon as possible after exposure. If you wait too long after being exposed, the medication may not be effective. Your doctor may also recommend vaccination after receiving this medication. Talk with your doctor about the best treatment for you.

If this medication is given after a liver transplant to prevent return of hepatitis B infection, it is given by injection into a vein by a healthcare professional. For this use, it should be given on a regular schedule. To help you remember, mark your calendar with an appointment reminder.

The dosage and schedule of injections is based on your medical condition, weight, and response to treatment.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Redness, pain, or tenderness at the injection site may occur. Nausea, vomiting, fever, chills, dizziness, headache, or back/joint pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist promptly.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Nabi-HB (hepatitis b vaccine recombinant) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections (such as hepatitis A) from the medication. Consult your doctor or pharmacist for more information.

Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your doctor or pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated.

Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain tests (including certain blood sugar tests, Coomb's test), possibly causing false test results. The blood sugar interference can lead to serious (possibly fatal) consequences. Tell all laboratory personnel and all your doctors and pharmacists that you use this medication, and which type of blood sugar testing strips you use.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: If you are receiving this medication on a regular schedule, laboratory and/or medical tests (such as levels of antibody in the blood) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor immediately to establish a new dosing schedule.

 

STORAGE: Not applicable. This medication is given in a hospital or doctor's office and will not be stored at home.

 

Information last revised June 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB

Generic Name: hepatitis B immune globulin (Pronunciation: HEP a TYE tis B im MYOON GLOB yoo lin)

  • What is hepatitis B immune globulin (Nabi-HB)?
  • What are the possible side effects of hepatitis B immune globulin (Nabi-HB)?
  • What is the most important information I should know about hepatitis B immune globulin (Nabi-HB)?
  • What should I discuss with my health care provider before receiving hepatitis B immune globulin (Nabi-HB)?
  • How is hepatitis B immune globulin given (Nabi-HB)?
  • What happens if I miss a dose (Nabi-HB)?
  • What happens if I overdose (Nabi-HB)?
  • What should I avoid while receiving hepatitis B immune globulin (Nabi-HB)?
  • What other drugs will affect hepatitis B immune globulin (Nabi-HB)?
  • Where can I get more information?

What is hepatitis B immune globulin (Nabi-HB)?

Hepatitis B immune globulin is made from human plasma containing proteins that protect against the type B form of hepatitis (inflammation of the liver).

Hepatitis B immune globulin is used to prevent hepatitis B in people receiving a liver transplant, and in babies born to mothers infected with hepatitis B. It is also used to prevent hepatitis B in people who have been exposed to contaminated blood products, or through household or sexual contact with an infected person.

Hepatitis B immune globulin is not a vaccine. Therefore it will not provide long-term protection from hepatitis B. For long-term protection you must receive a hepatitis B vaccine such as Engerix-B, Recombivax HB, or Twinrix.

Hepatitis B immune globulin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hepatitis B immune globulin (Nabi-HB)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • upset stomach, diarrhea;
  • tremors or shaking;
  • joint or back pain;
  • fever, chills;
  • headache; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Nabi-HB (hepatitis b vaccine recombinant) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about hepatitis B immune globulin (Nabi-HB)?

Hepatitis B immune globulin is not a vaccine. Therefore it will not provide long-term protection from hepatitis B. For long-term protection you must receive a hepatitis B vaccine such as Engerix-B, Recombivax HB, or Twinrix.

You should not receive this medication if you are allergic to human globulins, or if you have an immunoglobulin A deficiency. Hepatitis B immune globulin should not be injected into your muscle if you have a bleeding or blood clotting disorder such as hemophilia.

Hepatitis B immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with hepatitis B immune globulin. Your liver function will also need to be tested. Do not miss any scheduled visits to your doctor.

Do not receive a "live" vaccine while you are being treated with hepatitis B immune globulin, and for at least 3 months after your treatment ends. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Side Effects Centers
  • HepaGam B
  • HyperHep B
  • Nabi HB

Patient Detailed How Take

What should I discuss with my health care provider before receiving hepatitis B immune globulin (Nabi-HB)?

You should not receive this medication if you are allergic to human globulins, or if you have an immunoglobulin A deficiency. Hepatitis B immune globulin should not be injected into your muscle if you have a bleeding or blood clotting disorder such as hemophilia.

Hepatitis B immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether hepatitis B immune globulin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is hepatitis B immune globulin given (Nabi-HB)?

Hepatitis B immune globulin is given as an injection into a muscle or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection.

Hepatitis B immune globulin is given to liver transplant patients as part of the transplant procedure, and then for several weeks or months afterward. The medication is usually given to transplant patients as an IV (injected into a vein) every day for 7 days, then every 2 weeks for the next 11 weeks, followed by monthly injections from then on.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with hepatitis B immune globulin after your transplant. Your liver function will also need to be tested. Do not miss any scheduled visits to your doctor.

To protect against hepatitis B after exposure to the disease, this medication is usually given as soon as possible after exposure to an infected person. A booster medication is then given 24 hours later.

Babies born to mothers infected with hepatitis B should receive this medication within 12 hours of birth, or when the newborn is otherwise medically stable.

For people who have had sexual contact with someone infected with hepatitis B, this medication should be given within 14 days after the last contact. The medication may also be given at any time if contact with the infected person will continue.

Any infant whose parent or caregiver is infected with hepatitis B should receive this medication.

This medication can cause you to have unusual results with certain medical tests, including some blood glucose tests. Tell any doctor who treats you that you are receiving hepatitis B immune globulin.

Side Effects Centers
  • HepaGam B
  • HyperHep B
  • Nabi HB

Patient Detailed Avoid Taking

What happens if I miss a dose (Nabi-HB)?

Call your doctor for instructions if you miss a dose, or if you miss an appointment to have your injection given.

What happens if I overdose (Nabi-HB)?

An overdose of this medication is not expected to produce life-threatening side effects. Overdose symptoms may include pain or tenderness where the injection was given.

What should I avoid while receiving hepatitis B immune globulin (Nabi-HB)?

Do not receive a "live" vaccine while you are being treated with hepatitis B immune globulin, and for at least 3 months after your treatment ends. The live vaccine may not work as well during this time, and may not fully protect you from disease.

What other drugs will affect hepatitis B immune globulin (Nabi-HB)?

There may be other drugs that can interact with hepatitis B immune globulin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this medication written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.06. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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